Trial Outcomes & Findings for Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance. (NCT NCT02708966)

NCT ID: NCT02708966

Last Updated: 2021-02-02

Results Overview

After intervention by spectrophotometry

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2021-02-02

Participant Flow

Participant milestones

Measure	Gymnema Sylvestre Patients with impaired glucose tolerance (IGT) Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Overall Study STARTED	15	15
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Gymnema Sylvestre Patients with impaired glucose tolerance (IGT) Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

Baseline characteristics by cohort

Measure	Gymnema Sylvestre n=15 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=15 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Total n=30 Participants Total of all reporting groups
Age, Continuous	47 Years STANDARD_DEVIATION 10 • n=5 Participants	44 Years STANDARD_DEVIATION 7 • n=7 Participants	45 Years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Body Weight (BW)	79.6 kg STANDARD_DEVIATION 11.9 • n=5 Participants	79.1 kg STANDARD_DEVIATION 16.8 • n=7 Participants	79.3 kg STANDARD_DEVIATION 14.3 • n=5 Participants
Body Mass Index (BMI)	31.1 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	29.8 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	30.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants
Waist circumference (WC)	97.3 cm STANDARD_DEVIATION 6.9 • n=5 Participants	98.8 cm STANDARD_DEVIATION 9.8 • n=7 Participants	98 cm STANDARD_DEVIATION 8.3 • n=5 Participants
Systolic blood pressure (SBP)	117 mmHg STANDARD_DEVIATION 12 • n=5 Participants	119 mmHg STANDARD_DEVIATION 12 • n=7 Participants	118 mmHg STANDARD_DEVIATION 12 • n=5 Participants
Diastolic blood pressure (DBP)	77 mmHg STANDARD_DEVIATION 13 • n=5 Participants	77 mmHg STANDARD_DEVIATION 8 • n=7 Participants	77 mmHg STANDARD_DEVIATION 11 • n=5 Participants
Triglycerides (TGs)	1.8 mmol/L STANDARD_DEVIATION 1.3 • n=5 Participants	1.5 mmol/L STANDARD_DEVIATION 0.7 • n=7 Participants	1.7 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants
Total cholesterol (TC)	5.1 mmol/L STANDARD_DEVIATION 0.1 • n=5 Participants	5.2 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	5.1 mmol/L STANDARD_DEVIATION 0.9 • n=5 Participants
high-density lipoprotein cholesterol (HDL-C)	1.0 mmol/L STANDARD_DEVIATION 0.1 • n=5 Participants	0.9 mmol/L STANDARD_DEVIATION 0.3 • n=7 Participants	0.9 mmol/L STANDARD_DEVIATION 0.2 • n=5 Participants
Low-density lipoprotein cholesterol (LDL-C)	3.5 mmol/L STANDARD_DEVIATION 0.8 • n=5 Participants	3.5 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	3.5 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants
Very-low density lipoprotein (VLDL)	0.4 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	0.3 mmol/L STANDARD_DEVIATION 0.1 • n=7 Participants	0.3 mmol/L STANDARD_DEVIATION 0.2 • n=5 Participants
Fasting plasma glucose (FPG)	5.9 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants	5.6 mmol/L STANDARD_DEVIATION 0.4 • n=7 Participants	5.8 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants
2-hour postload plasma glucose (2-h PG)	9.1 mmol/L STANDARD_DEVIATION 1.2 • n=5 Participants	8.6 mmol/L STANDARD_DEVIATION 0.8 • n=7 Participants	8.9 mmol/L STANDARD_DEVIATION 1 • n=5 Participants
Glycated hemoglobin A1c	5.8 Percent of glycated hemoglobin STANDARD_DEVIATION 0.3 • n=5 Participants	5.6 Percent of glycated hemoglobin STANDARD_DEVIATION 0.2 • n=7 Participants	5.7 Percent of glycated hemoglobin STANDARD_DEVIATION 0.3 • n=5 Participants
Creatinine	79.5 µmol/L STANDARD_DEVIATION 17.7 • n=5 Participants	70.8 µmol/L STANDARD_DEVIATION 26.5 • n=7 Participants	70.8 µmol/L STANDARD_DEVIATION 17.7 • n=5 Participants
Area under the curve of glucose (AUCG)	1157 mmol/L/min STANDARD_DEVIATION 147 • n=5 Participants	1078 mmol/L/min STANDARD_DEVIATION 137 • n=7 Participants	1120 mmol/L/min STANDARD_DEVIATION 146 • n=5 Participants
Area under the curve of insulin (AUCI)	68,348 pmol/L/min STANDARD_DEVIATION 20,329 • n=5 Participants	63,544 pmol/L/min STANDARD_DEVIATION 28,041 • n=7 Participants	65946 pmol/L/min STANDARD_DEVIATION 24188 • n=5 Participants
Total insulin secretion	0.56 unitless STANDARD_DEVIATION 0.20 • n=5 Participants	0.54 unitless STANDARD_DEVIATION 0.22 • n=7 Participants	0.54 unitless STANDARD_DEVIATION 0.22 • n=5 Participants
First phase of insulin secretion	1297 unitless STANDARD_DEVIATION 550 • n=5 Participants	1391 unitless STANDARD_DEVIATION 712 • n=7 Participants	1344 unitless STANDARD_DEVIATION 627 • n=5 Participants
Insulin sensitivity	1.8 unitless STANDARD_DEVIATION 0.8 • n=5 Participants	2.5 unitless STANDARD_DEVIATION 1.5 • n=7 Participants	2.1 unitless STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Fasting Plasma Glucose	77.4 mmol/L Standard Deviation 11.6	77.7 mmol/L Standard Deviation 13.2

PRIMARY outcome

Timeframe: 90 days

The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
2-hour Post Load Plasma Glucose (2-h PG)	7.8 mmol/L Standard Deviation 1.7	7.9 mmol/L Standard Deviation 1.1

PRIMARY outcome

Timeframe: 90 days

After intervention by high-performance liquid chromatography

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Glycated Hemoglobin A1c (A1C)	5.4 Percent of glycated hemoglobin Standard Deviation 0.4	5.7 Percent of glycated hemoglobin Standard Deviation 0.5

PRIMARY outcome

Timeframe: 90 days

Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Total Insulin Secretion (Insulinogenic Index)	0.51 Unitless Standard Deviation 0.21	0.49 Unitless Standard Deviation 0.18

PRIMARY outcome

Timeframe: 90 days

First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0') after intervention.

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
First Phase of Insulin Secretion	1399 Unitless Standard Deviation 552	1528 Unitless Standard Deviation 677

PRIMARY outcome

Timeframe: 90 days

Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] after intervention.

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Insulin Sensitivity (Matsuda Index)	2.4 Unitless Standard Deviation 1.2	2.5 Unitless Standard Deviation 1.2

SECONDARY outcome

Timeframe: 90 days

Area under the curve of glucose was obtained using the trapezoidal integration.

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Area Under the Curve of Glucose	1075 mmol/l/min Standard Deviation 253	1018 mmol/l/min Standard Deviation 158

SECONDARY outcome

Timeframe: 90 days

After intervention area under the curve of insulin

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Area Under the Curve of Insulin	56968 mmol/l/min Standard Deviation 20787	53374 mmol/l/min Standard Deviation 20663

SECONDARY outcome

Timeframe: 12 weeks

The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Body Weight (BW)	77.4 kg Standard Deviation 11.6	77.7 kg Standard Deviation 13.2

SECONDARY outcome

Timeframe: 12 weeks

The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Body Mass Index (BMI)	30.3 kg/m^2 Standard Deviation 3.6	29.3 kg/m^2 Standard Deviation 4.4

SECONDARY outcome

Timeframe: 12 weeks

Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Waist Circumference (WC)	97.3 cm Standard Deviation 7.7	99 cm Standard Deviation 7.6

SECONDARY outcome

Timeframe: 12 weeks

The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Systolic Blood Pressure (SBP)	120 mmHg Standard Deviation 15	120 mmHg Standard Deviation 14

SECONDARY outcome

Timeframe: 12 weeks

The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Diastolic Blood Pressure (DBP)	75 mmHg Standard Deviation 10	77 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Total Cholesterol	4.7 mmol/L Standard Deviation 1.2	5.4 mmol/L Standard Deviation 1

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Triglycerides	1.7 mmol/L Standard Deviation 0.9	1.6 mmol/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
High Density Lipoprotein Cholesterol	0.9 mmol/L Standard Deviation 0.2	1.0 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Low Density Lipoprotein	2.5 mmol/L Standard Deviation 1.3	3.2 mmol/L Standard Deviation 1.6

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Very Low Density Lipoprotein	0.3 mmol/L Standard Deviation 0.2	0.3 mmol/L Standard Deviation 0.1

SECONDARY outcome

Timeframe: 90 days

After intervention by spectrophotometry

Outcome measures

Measure	Gymnema Sylvestre n=13 Participants Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=13 Participants Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Creatinine	70.8 µmol/L Standard Deviation 17.6	70.8 µmol/L Standard Deviation 17.6

Adverse Events

Gymnema Sylvestre

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gymnema Sylvestre n=15 participants at risk Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Placebo n=15 participants at risk Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Gastrointestinal disorders Diarrea	26.7% 4/15 • Adverse events were collected throughout the 90 days of the study	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study
Gastrointestinal disorders Abdominal distention	26.7% 4/15 • Adverse events were collected throughout the 90 days of the study	40.0% 6/15 • Adverse events were collected throughout the 90 days of the study
Gastrointestinal disorders Nausea	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study
Gastrointestinal disorders Anorexy	6.7% 1/15 • Adverse events were collected throughout the 90 days of the study	0.00% 0/15 • Adverse events were collected throughout the 90 days of the study
Gastrointestinal disorders Sweet taste intolerance	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study	0.00% 0/15 • Adverse events were collected throughout the 90 days of the study
Gastrointestinal disorders Dry mouth	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study	6.7% 1/15 • Adverse events were collected throughout the 90 days of the study
General disorders Polydipsia	6.7% 1/15 • Adverse events were collected throughout the 90 days of the study	0.00% 0/15 • Adverse events were collected throughout the 90 days of the study
Nervous system disorders Headache	13.3% 2/15 • Adverse events were collected throughout the 90 days of the study	20.0% 3/15 • Adverse events were collected throughout the 90 days of the study

Additional Information

Dra. Esperanza Martínez Abundis

Institute of Experimental and Clinical Therapeutics

Phone: +52-33-10-58-52-00

Email: esperanzamartnezabundi@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place